G/SPS/N/EU/498  
 
30 July 2021  
(21-5999) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  NOTIFICATION  
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved:   
2. Agency responsible:  European Commission, Health and Food Safety Directorate -General  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  Cypermethrin (pes ticide active substance)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners   
[ ] Specific regions or countries:   
5. Title of the notified document:  Draft Commission Implementing Regulation concerning 
renewing the approval of the active substance cypermethrin as a candidate for substitution 
in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council concerning the pla cing of plant protection products on the market, and amending 
the Annex to Commission Implementing Regulation (EU) No 540/2011 . Language(s):  
English . Number of pages:  5+7 
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4996_00_e.pdf  
https://members.wto.org/crnattachments/2021/SPS/EEC/21_4996_01_e.pdf  
6. Description of content:  This draft Commission Implementing Regulation provides that 
the approval of the active substance cypermethrin is renewed in accordance with 
Regulation (EC) No 1107/2009. It is however, necessary to include certain conditions and 
restrictions for spray applications outdoors to ensure the required protection level for 
aquatic organisms and non -targeted arthropods including bees is met.  
Existing authorised plant protection products containing cypermethrin will be reviewed in 
accordance with the conditions and restrictions set in this act. The conditions and 
restrictions ar e based on the first evaluation of the substance for use as a pesticide active 
substance in the E uropean Union under Regulation (EC) No 1107/2009. The substance was 
formerly approved under Directive 91/414/EEC.  
In order for an active substance to be approv ed in accordance with Regulation 
(EC) No 1107/2009 (concerning the placing of plant protection products on the market), 
it must be demonstrated that the substance is not harmful to human health, animal health 
or the environment. Criteria are listed in Arti cle 4 of the Regulation (and also detailed in 
Annex II thereto) which must be met to enable approval.  
During the evaluation and peer -review of cypermethrin, a number of concerns and areas 
that could not be finalised were identified. These are detailed in t he conclusion of the 
European Food Safety Authority (EFSA). In its Statement on risk mitigation measures on 
cypermethrin published on 4 October 2019, EFSA presented the levels of the necessary 
drift reduction and the measures that would be needed to demons trate low risk to the non -
target organisms, in particular aquatic organisms and non -target arthropods, including 
bees.  G/SPS/N/EU/498  
 
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  This means that cypermethrin meets the approval criteria as outlined in Regulation 
(EC) No 1107/2009 only if appropriate mitigation measu res to ensure the required 
protection level for aquatic organisms, non -targeted arthropods including bees are put in 
place for spray applications outdoors.  
Existing authorisations will need to be amended or withdrawn following renewal of 
authorisation in a ccordance with Article 43 of Regulation (EC) No 1107/2009.  
This decision only concerns the placing on the market of this substance and does not affect  
the Maximum Residue Levels (MRLs) for residues of the concerned active substance. Any 
action on  MRLs will  be subject to notification under the SPS procedure.  
This draft Commission Implementing Regulation was also notified under the 
TBT Agreement in notice G/TBT/N/EU/825.  
7. Objective and rationale: [X]  food safety, [X]  animal health, [X]  plant protection, 
[ ] protect humans from animal/plant pest or disease, [X]  protect territory from 
other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial num ber of Codex 
standard or related text) :  
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[X] None  
Does this proposed regulation conform to the relevant international standard?  
[ ] Yes   [  ] No 
If no, describe, whenever possible, how and why it deviates from the 
international standard:   
9. Other relevant documents and language(s) in which these are available:   
− Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 
21 October 2009 concerning the placing of plant protection products on the market 
and repealing Council Directives 79/117/EEC and 91/414/EEC  
http://eur -lex.europa.eu/legal -
content/EN/TXT/PDF/?uri=CELEX:32009R1107&qid=1437730988988&from=EN  
− Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the 
Council as regards the list of approved active substances (OJ L 153, 11  June 2011, 
p. 1-186) 
http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1442928512004&uri=CELEX:32011R0540  
− Conclusion on the peer review of the pesticide risk assessment of the active substance 
cypermethrin: EFSA Journal 2018;16(8):5402. Conclusion on t he peer review of the 
pesticide risk assessment of the active substance cypermethrin. Available online  
http://www.efsa.europa.eu  
− EFSA Statement on risk mitigation measures on cypermethrin  
https://www.efsa.europa.eu/en/efsajournal/pub/5822   
10. Proposed date of adoption (dd/mm/yy) : Fourth quarter of 2021  
Proposed date of publication (dd/mm/yy) : Fourth quarter of 2021  
11. Proposed date of entry into force: [  ] Six months from date of publication , and/or  
(dd/mm/yy) : 20 days following publication in the Official Journal of the European Union.  
[ ] Trade facilitating measure   G/SPS/N/EU/498  
 
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  12. Final date for comments: [  ] Sixty days from the date of circulation o f the 
notification and/or (dd/mm/yy) : Not applicable. Comments are only to be addressed 
to the TBT Enquiry Point on notice G/TBT/N/EU/825 and on TBT aspects of the notified 
draft legislation.  
Agency or authority designated to handle comments: [X]  National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address (if 
available) of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow -eu-tbt@ec.europa.eu  
13. Text(s) available from: [X]  National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2 299 80 43  
E-mail: grow -eu-tbt@ec.europa.eu